Trial Outcomes & Findings for Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (NCT NCT03767582)
NCT ID: NCT03767582
Last Updated: 2026-05-11
Results Overview
Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2026-05-11
Participant Flow
Participants with locally advanced pancreatic cancer (LAPC) were enrolled on the study prior to standard of care chemotherapy and Stereotactic Body Radiation Therapy (SBRT). After completing chemotherapy and SBRT, participants were re-screened to determine if they were eligible to continue on the study and receive study drug.
Participant milestones
| Measure |
Phase I - Dose Level 1
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
5
|
5
|
3
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=44 Participants
|
66.5 years
n=10 Participants
|
50 years
n=30 Participants
|
61 years
n=1054 Participants
|
61 years
n=97 Participants
|
61 years
n=488 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=44 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=1054 Participants
|
3 Participants
n=97 Participants
|
11 Participants
n=488 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=44 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
11 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=44 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=1054 Participants
|
3 Participants
n=97 Participants
|
21 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1054 Participants
|
1 Participants
n=97 Participants
|
4 Participants
n=488 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=44 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=1054 Participants
|
2 Participants
n=97 Participants
|
16 Participants
n=488 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=44 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=1054 Participants
|
3 Participants
n=97 Participants
|
22 Participants
n=488 Participants
|
|
Histology Grade at Diagnosis
Moderately Differentiated
|
2 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=1054 Participants
|
1 Participants
n=97 Participants
|
11 Participants
n=488 Participants
|
|
Histology Grade at Diagnosis
Moderate to Poorly Differentiated
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
|
Histology Grade at Diagnosis
Poorly Differentiated
|
0 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=1054 Participants
|
2 Participants
n=97 Participants
|
7 Participants
n=488 Participants
|
|
Histology Grade at Diagnosis
Unknown
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsNumber of participants who experienced study drug-related toxicities as defined by CTCAE v5.0
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Study Drug-related Adverse Events
Any Study Drug-Related AE
|
3 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Study Drug-related Adverse Events
Hyperthyroidism
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Dry mouth
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Stomach pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Edema limbs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Fatigue
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Fever
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Malaise
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Lymphocyte account decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Anorexia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Dehydration
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Back pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Myalgia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Headache
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Dysuria
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Urine output decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Cough
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Dyspnea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Pneumonitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Dry skin
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Erythema mutliforme
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Pruritus
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Study Drug-related Adverse Events
Rash maculo-papular
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Bruising at vaccine sites
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Erythema at vaccine sites
|
2 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Induration at vaccine sites
|
1 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Swelling at vaccine sites
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Study Drug-related Adverse Events
Tenderness at vaccine sites
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Pruritus at vaccine sites
|
2 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Study Drug-related Adverse Events
Chills
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: Only patients who completed surgical resection or had a biopsy done at time of aborted surgery and had with matched pre- and post-treatment tumor samples were evaluable for the tumor immune response endpoint.
Number of participants who had \>80% increase of infiltration of CD8+CD137+ T cells into their tumors after treatment with SBRT and immunotherapy. Baseline biopsies were collected at time of fiducial placement for SBRT (after completion of chemotherapy) and post-treatment tumor was collected at time of surgical resection
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Tumor Immune Response (CD8+ CD137+ Tumor Infiltration)
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsNumber of months from start of immunotherapy until death from any cause
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
8.2 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
12.3 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
13.4 months
Interval 8.0 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
11.7 months
Interval 7.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
13.7 months
Interval 5.2 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 3 yearsNumber of months from the start of immunotherapy until first documented distant metastases on radiographic imaging or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Metastasis Free Survival (MFS)
|
1.2 months
Interval 0.5 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
8.4 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
3.6 months
Interval 3.4 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
7.4 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
11.3 months
Interval 3.6 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 3 yearsNumber of months from the start of immunotherapy until first documented local progression on radiographic imaging or death from any cause, whichever occurs first. Local progression is defined as appearance of new lesions in the pancreas or surgical resection bed (for surgically resected patients) or clinically meaningful tumor growth in the primary pancreas tumor (for patients that were not surgically resectable).
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Local Progression Free Survival (LPFS)
|
NA months
Insufficient number of local progression events
|
8.7 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
NA months
Insufficient number of local progression events
|
7.4 months
Interval 5.1 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
11.3 months
Interval 11.3 to
Upper bound confidence interval was not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 7 monthsNumber of participants who are able to undergo successful tumor resection (as defined by R0 and R1 resection).
Outcome measures
| Measure |
Phase I - Dose Level 1
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Surgical Resectability Rate
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: Only participants that completed surgical resection were evaluable for pathologic response
Number of participants who with a moderate, marked, or complete pathologic response after chemotherapy, SBRT, and one cycle of immunotherapy as determined by surgical margins and residual disease. Tumor response grading Complete response (grade 0): no viable residual cancer cells Marked response (grade 1): single cells or rare small groups of cancer cells Moderate response (grade 2): residual cancer outgrown by fibrosis Poor or no response (grade 3): extensive residual cancer
Outcome measures
| Measure |
Phase I - Dose Level 1
n=1 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=5 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=4 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=3 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=1 Participants
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Pathological Response Rate
poor or no response (grade 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pathological Response Rate
complete response (grade 0)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pathological Response Rate
marked response (grade 1)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Pathological Response Rate
moderate response (grade 2)
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Phase I - Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I - Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase II - Arm A: Nivolumab + BMS-813160
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase I - Dose Level 1
n=3 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
gastric ulcer
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Biliary tract infection
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
Other adverse events
| Measure |
Phase I - Dose Level 1
n=3 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (150 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 150 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase I - Dose Level 2
n=6 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm A: Nivolumab + BMS-813160
n=5 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks and Nivolumab every 4 weeks for a total of 6 doses.
|
Phase II - Arm B: Nivolumab + GVAX + BMS-813160
n=5 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily), Nivolumab (480 mg IV on Day 1 of each cycle), and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle).
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: BMS-813160 300 mg twice daily for 24 weeks, Nivolumab every 4 weeks for a total of 6 doses, and GVAX once.
|
Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5)
n=3 participants at risk
Chemotherapy: 8 to 16 14-day cycles of FOLFIRINOX-based chemotherapy (patients may switch to Gemcitabine-based therapy due to intolerability).
Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy over 5 days given 2-4 weeks after chemotherapy
Surgery: pancreatic resection (if candidate) between Cycle 1 and 2 of immunotherapy.
Immunotherapy:
BMS-813160 (300 mg oral, twice daily) and Nivolumab (480 mg IV on Day 1 of each cycle) for Cycle 1. Nivolumab and GVAX (5x10\^6 cells as 6 intradermal injections on Day 2 of each cycle) for Cycle 2-5.
Immunotherapy Cycle 1 is 1-2 weeks after SBRT and 2 weeks prior to surgery. Cycles 2-5 are each 4 weeks long and start 6-12 weeks after surgery (or 4 weeks after Cycle 1 for patients who are not surgical candidates but do not have metastatic disease).
Maintenance Phase: Nivolumab every 4 weeks for a total of 6 doses and GVAX once.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
80.0%
4/5 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
60.0%
3/5 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
66.7%
2/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
60.0%
3/5 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Fever
|
66.7%
2/3 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
General disorders
Pain at site of port
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Shingles
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Serum amylase increased
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
66.7%
2/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Renal and urinary disorders
Urine output decreased
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Mole
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
66.7%
2/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
50.0%
3/6 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Bruising at vaccine sites
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Erythema at vaccine sites
|
66.7%
2/3 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
83.3%
5/6 • Number of events 5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
80.0%
4/5 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Induration at vaccine sites
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
100.0%
6/6 • Number of events 6 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus at vaccine sites
|
66.7%
2/3 • Number of events 4 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
83.3%
5/6 • Number of events 7 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
100.0%
5/5 • Number of events 7 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Swelling at vaccine sites
|
33.3%
1/3 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
60.0%
3/5 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
33.3%
1/3 • Number of events 3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Tenderness at vaccine sites
|
33.3%
1/3 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/5 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
0.00%
0/3 • Adverse Events were collected from first dose of study drug up to 18 months. Subjects were followed for survival for up to 3 years.
|
Additional Information
Eric Christenson, MD
Sidney Kimmel Cancer Center at Johns Hopkins
Phone: 410-955-8893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place